16 results
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30ms
·
Sources: EU EUDAMED, US FDA
Well Lead Ureteral Access Sheath
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AGC TRADITION KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304241008·
Sasmar Vanilla
FDA UDI
Sasmar Pharmaceuticals SPRL·09337213008266·PERSONAL LUBRICANT
BD VACUTAINER® PLUS BLOOD COLLECTION TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·March 15, 2022
CASPIAN SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE
FDA 510(k)
FDA Class 2
·Cardiovascular
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code FPA·June 6, 2013
ASR ACETABULAR IMPLANT 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LT.D·Product code KWA·June 30, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008
LIFE SCOPE G9
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·June 13, 2024
LIFE SCOPE G9
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·October 27, 2023
Precise Digital Accelerator Delivery of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 26, 2012
Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 20, 2013
SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 26, 2014
Precise Treatment Table. To be used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 17, 2013
All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 12, 2014